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FDA 510(k) Application Details - K992732
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K992732
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO M1S 3S4 CA
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Contact
SAM LAKHANI
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
FOZ
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More FDA Info for this Product Code
Date Received
08/13/1999
Decision Date
04/20/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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